Comparison of effectiveness and safety of immunotherapy of warts with intralesional versus subcutaneous MMR vaccine: An open label randomized, parallel group, clinical trial

Abstract

Common wart, also known as verruca vulgaris is characterized by focal proliferation of keratinocytes caused by multiple strains of human papilloma virus (HPV). Conventional treatments like chemical cautery, cryotherapy, electro-cautery, etc often fail to cure verruca satisfactorily. The present work was a randomized, parallel-group, non-inferiority clinical trial with an objective of comparing the effectiveness and safety of subcutaneous MMR versus intralesional MMR vaccine in the treatment of multiple warts. Method: Consenting patients of both sexes of 18-65 years age, who have viral warts and did not receive anti-wart treatment in the last 4 weeks and devoid of any active bacterial or viral skin diseases were included in the study. Interventions: Eligible patients were randomized into either group A (receiving 0.3 ml of intralesional MMR) or group B (receiving 0.5 ml of subcutaneous MMR). A total of three injections were administered at two weeks interval. Outcome Measure: The response was considered complete if there was disappearance of the wart(s) and return of the normal skin markings, partial if the wart(s) was regression in size by 50-99% and no response if there was be 0-49% decrease in wart size. Results: Thirty patients were recruited in each group; 5 of group A and 3 of group B were lost to follow up. Modified intention to treat analysis was performed, so, the last observation of such patients was carried forward and all 60 participants were analysed. Number of warts and size of the largest wart were declined significantly (P < 0.001 and P = 0.001 respectively) in both the treatment arms. No significant difference between two groups were seen. Complete clearance including distant lesions was achieved in 22 patients; 12 (48%) in group A and 10 (37.04%) in group B, but the final outcome at the end of the study showed no significant difference between the two t groups. (P = 0.64). Adverse Events: Only one patient had developed mild fever with tender, enlarged parotid gland after first injection of subcutaneous MMR which resolved within two weeks. Conclusion: Efficacy and safety profile of Subcutaneous and intralesional MMR were almost same. Both can be considered as safe and cost effective treatment of warts while the subcutaneous route may be easier to administer.

Keywords

• intralesional
• mmr
• subcutaneous
• wart